Systems and methods for automatically removing a needle cap of an autoinjector

ABSTRACT

An autoinjector device includes a dose cassette having an outer container and a needle cap having a base with a diameter larger than the outer container of the dose cassette. The autoinjector device further include a housing for receiving the dose cassette, a clasp mechanism configured to hold the dose cassette within the housing, and an actuator configured to move the dose cassette proximally within the housing after the dose cassette is secured within the housing. The movement of the dose cassette causes the base of the needle cap to mechanically engage with a distal end of the housing, and the mechanical engagement between the base of the needle cap and the distal end of the housing causes the needle cap to separate from the dose cassette.

PRIORITY CLAIM

This application is a 371 U.S. National Stage application ofInternational Application No. PCT/US2019/024086 filed Mar. 26, 2019,which claims priority to U.S. Provisional Application Nos. 62/648,762filed Mar. 27, 2018, 62/648,766 filed Mar. 27, 2018, 62/648,770 filedMar. 27, 2018 and 62/648,772 filed Mar. 27, 2018, their entire contentsare incorporated herein by reference and relied upon.

TECHNICAL FIELD

The present disclosure relates to drug delivery with an injector device.In particular, several embodiments are directed to motor-driven deliveryof medicaments with an electronic autoinjector device with a linearactuator.

BACKGROUND

Patients suffering from many chronic conditions must frequently injectthemselves with medicament. A variety of drug delivery devices known asautoinjectors have been developed to enable a person to conveniently andreliably self-inject medicament. These devices utilize a liquidmedicament for injecting into the person. Forward movement of a plungerresults in the medicament being dispensed from an outlet opposite of theplunger.

Electronic autoinjectors have several advantages over purely mechanicalautoinjectors, including clear user feedback, multiple delivery speedsand constant delivery force. However, for economic reasons, electronicautoinjectors are typically reusable, requiring the user to performextra loading steps of a disposable syringe or dose cassette. Manyelectronic autoinjectors also use the motor drive mechanism to insertthe needle into the user's tissue, resulting in a slower insertionprocess that can result in the perception of more pain.

SUMMARY

It is an object of the present disclosure to provide an electronicautoinjector device that reduces the number of manual steps, includingrapid needle insertion for lower pain perception.

A device includes a motor having a hollow drive shaft. The motor isconfigured to rotate the hollow drive shaft. A lead screw nut isoperably connected to the hollow drive shaft. The lead screw nut isconfigured to rotate upon rotation of the hollow drive shaft. A leadscrew is operably connected to the lead screw nut. The lead screw isconfigured to move within the lead screw nut and the lead screw isconfigured to pass through at least part of the hollow drive shaft.

A method includes rotating, by a motor, a hollow drive shaft. The methodfurther includes rotating, in response to rotation of the hollow driveshaft, a lead screw nut operably connected to the hollow drive shaft.The method further includes moving, in response to rotation of the leadscrew nut, a lead screw operably connected to the lead screw nut. Thelead screw is configured to pass through at least part of the hollowdrive shaft.

An autoinjector device includes a controller, a plunger drive unit, amotor controlled by the controller, and a hollow drive shaft. The motoris configured to rotate the hollow drive shaft. The autoinjector devicefurther includes a gear box operably connected to the hollow drive shaftand a lead screw nut operably connected to the gear box. The lead screwnut is configured to rotate in response to a rotational force from thehollow drive shaft exerted on the lead screw nut via the gear box. Theautoinjector device further includes a lead screw operably connected tothe lead screw nut. The lead screw is configured to move within the leadscrew nut and is configured to pass through at least part of the hollowdrive shaft. Movement of the lead screw in response to rotation of thelead screw nut is configured to cause a plunger head driver at a distalend of the lead screw to engage the plunger drive unit upon to dispensea medicament.

An autoinjector device includes a dose cassette. The dose cassetteincludes an outer container and a needle cap having a base with adiameter larger than the outer container. The autoinjector devicefurther includes a housing configured to receive the dose cassette and aclasp mechanism configured to secure the dose cassette within thehousing. The autoinjector device further includes an actuator configuredto move the dose cassette proximally within the housing after the dosecassette is secured within the housing. The movement of the dosecassette causes the base of the needle cap to mechanically engage with adistal end of the housing. The mechanical engagement between the base ofthe needle cap and the distal end of the housing causes the needle capto separate from the dose cassette.

A method includes receiving a dose cassette into a housing. The dosecassette includes an outer container and a needle cap having a base witha diameter larger than the outer container. The method further includessecuring the dose cassette within the housing using a clasp mechanism.The method further includes moving the dose cassette proximally withinthe housing after the dose cassette is secured within the housing. Themethod further includes separating the needle cap from the dose cassettebecause of mechanical engagement between a distal end of the housing andthe needle cap.

A dose cassette device includes an outer container and a needle caphaving a base with a diameter larger than the outer container of thedose cassette. The outer container is configured to be inserted into ahousing of an autoinjector. The base of the needle cap is configured tomechanically engage with a distal end of the housing. The needle cap isconfigured to separate from the outer container because of themechanical engagement between the distal end of the housing and the baseof the needle cap.

An autoinjector housing device includes a housing configured to receivea dose cassette having an outer container and a needle cap. The needlecap includes a base with a diameter larger than the outer container ofthe dose cassette. The autoinjector housing device further includes aclasp mechanism configured to secure the dose cassette within thehousing. The autoinjector housing device further includes an actuatorconfigured to move the dose cassette proximally within the housing afterthe dose cassette is secured within the housing. The movement of thedose cassette causes the base of the needle cap to mechanically engagewith a distal end of the housing. The mechanical engagement between thebase of the needle cap and the distal end of the housing causes theneedle cap to separate from the dose cassette.

An autoinjector housing device includes a housing configured to receivea dose cassette and a base latch configured to secure the dose cassettewithin the housing. The autoinjector housing device further includes aback plate operably connected to a spring. The back plate is configuredto move proximally within the housing upon receipt of the dose cassetteinto the housing. The proximal movement of the back plate compresses thespring. The autoinjector housing device further includes an actuatoroperably connected to the base latch. The actuator is configured to movethe base latch and the dose cassette proximally within the housing afterthe dose cassette is secured in the housing. The base latch isconfigured to move radially outwards upon said proximal movement of thebase latch within the housing. The radial movement of the base latch isconfigured to cause the dose cassette to become unsecured within thehousing. In response to the dose cassette becoming unsecured, the springis configured to decompress. The decompression of the spring isconfigured to move the back plate distally and push the dose cassetteout of a distal end of the housing.

A method includes receiving a dose cassette at a housing of anautoinjector device. The method further includes securing the dosecassette within the housing using a base latch. The method furtherincludes moving a black plate operably connected to a spring. The backplate moves proximally within the housing upon receipt of the dosecassette into the housing. The method further includes compressing thespring as a result of the proximal movement of the back plate within thehousing. The method further includes moving, by an actuator operablyconnected to the base latch, the dose cassette and the base latchproximally within the housing after the dose cassette is secured in thehousing. The method further includes ejecting the dose cassette from thehousing in response to the proximal movement of the base latch and thedose cassette. The ejection of the dose cassette includes moving thebase latch radially outwards upon said proximal movement of the baselatch within the housing. The movement of the base latch causes the dosecassette to become unsecured within the housing. The ejection of thedose cassette further includes decompressing the spring in response tothe dose cassette becoming unsecured. The ejection of the dose cassettefurther includes moving the back plate distally within the housing as aresult of the decompression of the spring. The movement of the backplate pushes the dose cassette out of a distal end of the housing.

An autoinjector device includes a needle, a housing, and a primarycontainer operably connected to the needle. The primary container isconfigured to move axially within the housing. The autoinjector devicefurther includes a ledge fixed with respect to the housing and a firstspring. A first end of the first spring is operably connected to theprimary container and a second end of the first spring is operablyconnected to the housing. The autoinjector device further includes alatching mechanism operably connected to the primary container. Theautoinjector device further includes a second spring. A first end of thesecond spring is operably connected to the latching mechanism and asecond end of the second spring is operably connected to the primarycontainer. The autoinjector device further includes a linear actuatorconfigured to move axially within the housing. In a first state, thelatching mechanism is biased toward the ledge by the second spring andthe primary container and the needle are fixed within the housing basedon mechanical engagement between the latching mechanism and the ledge.In a second state, the linear actuator engages and moves the latchingmechanism such that the latching mechanism no longer mechanically engagewith the ledge and the primary container and the needle, in response tothe movement of the latching mechanism, move distally with respect tothe housing based on an energy stored in the first spring.

A method includes moving a linear actuator axially within a housing toengage the linear actuator with a latching mechanism operably connectedto a primary container. The primary container is operably connected to aneedle and is configured to move axially within the housing. A firstspring has a first end operably connected to the primary container and asecond end operably connected to the housing. The latching mechanism isoperably connected to the primary container and is biased toward a ledgeby a second spring. The ledge is fixed with respect to the housing. Thesecond spring has a first end operably connected to the latchingmechanism and a second end operably connected to the primary container.The primary container and the needle are fixed within the housing basedon mechanical engagement between the latching mechanism and the ledgebefore the linear actuator is engaged with the latching mechanism. Themethod further includes moving, in response to engagement of the linearactuator with the latching mechanism, the latching mechanism such thatthe latching mechanism no longer mechanically engages with the ledge.The method further includes moving, in response to the movement of thelatching mechanism, the primary container and the needle distally withrespect to the housing based on an energy stored in the first spring.

BRIEF DESCRIPTION OF THE DRAWINGS

Many aspects of the present disclosure can be better understood withreference to the following drawings. The components in the drawings arenot necessarily to scale. Instead, emphasis is placed on illustratingclearly the principles of the present disclosure. Furthermore,components can be shown as transparent in certain views for clarity ofillustration only and not to indicate that the illustrated component isnecessarily transparent. For ease of reference, throughout thisdisclosure identical reference numbers may be used to identify identicalor at least generally similar or analogous components or features.

FIG. 1 is a perspective view of a reusable autoinjector base and a dosecassette in accordance with the disclosed embodiments.

FIG. 2 is a perspective view of another reusable autoinjector base andmultiple dose cassettes in accordance with the disclosed embodiments.

FIG. 3 is a sectioned perspective view of a reusable autoinjector basein accordance with the disclosed embodiments.

FIG. 4 is a perspective view of a linear actuator with a hollow driveshaft and a gear box in accordance with the disclosed embodiments.

FIG. 5 is a sectioned perspective view of a motor with a hollow driveshaft and a lead screw in accordance with the disclosed embodiments.

FIG. 6 is a sectioned perspective view of a linear actuator and a gearbox in accordance with the disclosed embodiments.

FIG. 7 is another sectioned perspective view of a linear actuator and agear box in accordance with the disclosed embodiments.

FIG. 8 is a cross-section view of a linear actuator and a gear box inaccordance with the disclosed embodiments.

FIG. 9 is a sectioned perspective view of a reusable autoinjector basein accordance with the disclosed embodiments.

FIG. 10 is a cross-section view of a reusable autoinjector base inaccordance with the disclosed embodiments.

FIG. 11 is a perspective view of a dose cassette in accordance with thedisclosed embodiments.

FIG. 12 is a sectioned perspective view of a dose cassette in accordancewith the disclosed embodiments.

FIG. 13 is a sectioned perspective view of a portion of a dose cassettein accordance with the disclosed embodiments.

FIG. 14 is a cross section view of a dose cassette in accordance withthe disclosed embodiments.

FIG. 15 is a sectioned perspective view of a reusable autoinjector baseand a dose cassette just prior to the dose cassette being inserted intothe reusable autoinjector base in accordance with the disclosedembodiments.

FIG. 16 is a sectioned perspective view during an insertion of a dosecassette into a reusable autoinjector base in accordance with thedisclosed embodiments.

FIG. 17 is a sectioned perspective view of a dose cassette locked into areusable autoinjector base in accordance with the disclosed embodiments.

FIG. 18 is a cross section view of a dose cassette locked into areusable autoinjector base in accordance with the disclosed embodiments.

FIG. 19 is a sectioned perspective view of a dose cassette within ahousing of a reusable autoinjector base in accordance with the disclosedembodiments.

FIG. 20 is a sectioned perspective view of a needle cap of a dosecassette beginning to be removed in accordance with the disclosedembodiments.

FIG. 21 is a sectioned perspective view of a needle cap of a dosecassette contacting a sensor of a reusable autoinjector base inaccordance with the disclosed embodiments.

FIG. 22 is a sectioned perspective view of a needle cap of a dosecassette being removed in accordance with the disclosed embodiments.

FIG. 23 is a cross section view of a needle cap of a dose cassette beingremoved in accordance with the disclosed embodiments.

FIG. 24 is a sectioned perspective view of a dose cassette locked inplace in advance of a needle protruding from the dose cassette inaccordance with the disclosed embodiments.

FIG. 25 is a sectioned perspective view of a needle protruding from adose cassette in accordance with the disclosed embodiments.

FIG. 26 is a cross section view of a needle protruding from a dosecassette in accordance with the disclosed embodiments.

FIG. 27 is a sectioned perspective view of a dose cassette beingunlocked from a reusable autoinjector base in accordance with thedisclosed embodiments.

FIG. 28 is a cross section view of a dose cassette being unlocked from areusable autoinjector base in accordance with the disclosed embodiments.

FIG. 29 is a sectioned perspective view of a dose cassette being ejectedfrom a reusable autoinjector base in accordance with the disclosedembodiments.

FIG. 30 is a sectioned perspective view of an ejected dose cassette inaccordance with the disclosed embodiments.

FIG. 31 is a flow diagram illustrating a method for utilizing a linearactuator with a hollow drive shaft in accordance with the disclosedembodiments.

FIG. 32 is a flow diagram illustrating a method for removing a needlecap from a dose cassette in accordance with the disclosed embodiments.

FIG. 33 is a flow diagram illustrating a method for ejecting a dosecassette from a reusable autoinjector base in accordance with thedisclosed embodiments.

FIG. 34 is a flow diagram illustrating a method for unlocking a dosecassette from a reusable autoinjector base in accordance with thedisclosed embodiments.

FIG. 35 is a flow diagram illustrating a method for needle insertionfrom a dose cassette in accordance with the disclosed embodiments.

FIG. 36 is a block diagram illustrating an autoinjector and servercomputing devices in accordance with the disclosed embodiments.

DETAILED DESCRIPTION

The present technology is directed to apparatuses, systems, methods, andcomputer readable media for a medical autoinjector. In some embodiments,the autoinjector includes a reusable autoinjector base and disposabledose cassettes, which may be disposed of after one or more uses. Thedose cassettes can be inserted into the autoinjector, which in turnautomatically dispenses a medicament and records that the medicament wasdispensed. In some embodiments, the autoinjector may be reusable. Insome embodiments, instead of having a separate disposable dose cassette,the entire autoinjector may be disposable after one or more uses. Insome embodiments, the autoinjector may be used repeatedly during for apredetermined amount of time.

Advantageously the embodiments described herein include a single-motordriven mechanism that automates processes for removing a needle cap,rapidly inserting a needle to patients, delivering drug/medicament,retracting the needle, and/or ejecting a dose cassette.

As described herein, an autoinjector includes a linear actuator havingan electric motor. The electric motor has a hollow drive shaft, whichallows a lead screw to pass through the center of the motor. Thus, thehollow drive shaft enables the autoinjector to have a smaller overallfootprint compared to implementations where a motor is adjacent to alead screw and the lead screw is connected to the motor via an outputshaft and a gearbox. For handheld medical devices such as autoinjectors,a small footprint is desirable, especially so that such devices can havecompact, cylindrical footprints. In some embodiments, additional stagesmay be added concentrically to a gearbox that has a hollow center. Thehollow center of the gearbox may be aligned with the hollow drive shaftof the motor. Thus, such a configuration of the gearbox cansignificantly increase the torque output without significantly adverselyaffecting the overall footprint of the autoinjector.

Also described herein are embodiments for automated needle cap removalof an autoinjector. Automated needle cap removal has several benefits.First, automating removal of a needle cap ensures that the needle cap isproperly removed to lower the chance of: a device malfunction, patientinjury, and improperly delivered medicament. Such features may beespecially beneficial for users with physical or mental challenges thatmake handling an injection device and/or following multiple steps forusing an injection device difficult. The automated needle cap removaldescribed herein may ensure (e.g., using sensors) that a needle cap wasproperly removed before proceeding with an injection process.

Also described herein are embodiments for automated rapid needleinsertion of an injection device. In various embodiments, the insertionof a needle into a user's skin is automated and not in direct responseto a button press or other action performed by the user. In other words,in various embodiments, an injection device first determines whetherconditions are proper for an injection (e.g., dose cassette properlyinserted, device properly placed on skin, needle cap properly removed,etc.) and then automatically initiates the injection (i.e., insertion ofa needle) after determining that the conditions are proper without aparticular button press or other action performed by the user. This canhelp abstract the injection process away from the user, reducing anxietythat may be associated with needles and injections for some users. Thevarious embodiments of automated needle insertion described herein alsoprovide for mechanisms that ensure a needle is inserted to the correctdepth so that medicament is properly delivered. With a manual insertion,needle insertion depth may not always be ideal. The needle insertiondescribed herein also occurs rapidly (e.g., through a spring-driveninsertion) compared to a manual insertion process, reducing the amountof time the tissue is being disrupted by a needle and thereby improvingthe overall comfort for the user during the injection process. The rapidneedle insertion embodiments disclosed herein may be used with any typeof autoinjection device, whether the device uses disposable dosecassettes or not.

Various embodiments disclosed herein also provide for automated dosecassette ejection for autoinjectors that utilize a reusable autoinjectorbase and disposable dose cassettes. Automatically removing a used dosecassette after completion of an injection reduces the amount time a userneeds to handle the dose cassette that has a needle and ensures thatdose cassette is removed properly, thereby reducing the possibility ofinjury to the user and/or damage to a reusable autoinjector base. Thisadvantageously simplifies the steps that a user needs to perform, whichmay be particularly beneficial for any user with physical or mentalchallenges that affect usage of an injection device.

Specific details of several embodiments of the technology are describedbelow with reference to FIGS. 1-36. Although many of the embodiments aredescribed below with respect to devices, systems, methods, and computerreadable media for improved autoinjectors, other applications and otherembodiments in addition to those described herein are within the scopeof the technology. Additionally, several other embodiments of thetechnology can have different configurations, components, or proceduresthan those described herein. A person of ordinary skill in the art,therefore, will accordingly understand that the technology can haveother embodiments with additional elements, or the technology can haveother embodiments without several of the features shown and describedbelow with reference to FIGS. 1-36.

Overview

FIG. 1 is a perspective view of a reusable autoinjector base 1000 and adose cassette 100 in accordance with the disclosed embodiments. Dosecassettes may also be referred to herein as a pod. The reusableautoinjector base 1000 includes interfaces 500. Interfaces 500 mayinclude, for example, LEDs (light emitting diodes), buttons, screens,and/or other types of user interfaces for communicating a state of theautoinjector, dose cassette, medicament, or other aspect to the user orto receive inputs from the user. The dose cassette 100 is sized to fitwithin an opening (not shown) in the reusable autoinjector base 1000,but exists on a distal end (the left end in FIG. 1) of a housing of thereusable autoinjector base 1000. Once the dose cassette 100 is insertedin the reusable autoinjector base 1000, a medicament stored in the dosecassette 100 can be delivered as described below.

FIGS. 2 and 3 are discussed together below, as they each show differentviews of a reusable autoinjector base 1000 and/or dose cassettes 100.FIG. 2 is a perspective view of a reusable autoinjector base 1000 andmultiple dose cassettes 100 in accordance with the disclosedembodiments. FIG. 3 is a sectioned perspective view of the reusableautoinjector base 1000 in accordance with the disclosed embodiments.

As shown in FIGS. 2-3, the reusable autoinjector base 1000 includes,among other things, an LED interface 500, an activation button 550, alinear drive mechanism including a linear actuator 600, embedded systems701, a clasp mechanism 805. Once a dose cassette is successfullyinserted into the reusable autoinjector base 1000, the activation button550 may be pressed to initiate needle cap removal, injection, needlewithdrawal, and/or dose cassette ejection.

The LED interface 500 may indicate various information such as whetheran injection was successful and/or whether the dose cassette wassuccessfully inserted in the reusable autoinjector base 100. As furtherdescribed below, the dose cassettes 100 is sized to fit into thereusable autoinjector base 1000, such that medicament stored in the dosecassettes 100 can be dispensed into a user.

The linear drive mechanism may arranged to drive a plunger (e.g., of asyringe), thereby causing dispensation of the medicament in thesecondary container (e.g., the dose cassette 100). The linear drivemechanism may be further arranged to actuate the needle insertion andretraction mechanism within the dose cassettes 100 and to actuate a dosecassette 100 release/ejection mechanism.

The clasp mechanism 805, as will be described in greater detail below,locks/secures the dose cassette 100 within the reusable autoinjectorbase 1000 and releases the dose cassette 100 after the injection iscomplete and the needle is retracted back into the dose cassette.

The embedded systems 701 may include a printed circuit board (PCB)having various integrated circuits and passive components, a radiofrequency transmitter to transmit data, and/or a battery. The embeddedsystems 701 may be configured to receive signals from, for example, aradio frequency identification (RFID) reader. The embedded systems 701may also be configured to send control signals to the linear drivemechanism.

Linear Actuators

FIGS. 4-8 are discussed together below, as they each show differentviews of a linear actuator as described herein. FIG. 4 is a perspectiveview of a linear actuator 600 including a motor 630 having hollow driveshaft and a gear box 700 in accordance with the disclosed embodimentsthe disclosed embodiments. FIG. 5 is a sectioned perspective view of amotor 630 having a hollow drive shaft and a lead screw 620 in accordancewith the disclosed embodiments. FIG. 6 is a sectioned perspective viewof a linear actuator 600 and a gear box 700 in accordance with thedisclosed embodiments. FIG. 7 is another sectioned perspective view of alinear actuator 600 and a gear box 700 the disclosed embodiments inaccordance with the disclosed embodiments. FIG. 8 is a cross-sectionview of a linear actuator 600 and a gear box 700 in accordance with thedisclosed embodiments.

As discussed above, the linear actuator 600 may be utilized in anautoinjector (e.g., in the reusable autoinjector base 1000 describedherein). As shown in FIGS. 4-8, the linear actuator 600 includes themotor 630, the gearbox 700, the lead screw 620, and a plunger headdriver 610. The motor 630 is of a brushed DC motor design that has ahollow drive shaft to allow the lead screw 620 to move through themiddle of the motor 630. Although a brushed DC motor is shown in FIGS.4-8, other types of motors may also be utilized. The lead screw 620 canmove proximally and distally with respect to a plane of lead screw 620′srotation via a lead screw nut 670. The lead screw nut 670 is attached tothe gearbox 700, which in turn is attached to the hollow drive shaft ofthe motor 630. Accordingly, as the hollow drive shaft is turned (e.g.,when motor 630 is powered), the lead screw nut 670 is alsoturned/rotated via gears in gearbox 700. Depending on the direction ofrotation of the hollow drive shaft, the lead screw 620 can may moveproximally or distally through the hollow center of the motor 630. Thus,the plunger head driver 610, which is fixed to the lead screw 620, moveswith the lead screw 620 proximally or distally to engage the variousaspects of an autoinjector to implement the various features of thedisclosed autoinjector (e.g., removing a needle cap, rapidly inserting aneedle to patients, delivering drug/medicament, retracting the needle,and/or ejecting a dose cassette). In addition, the gearbox 700 may alsohave a hollow center that is aligned with the hollow center of the motor630 such that that the lead screw 620 can move proximally or distallythrough both the center of the motor 630 and the center of the gearbox700.

As utilized herein, when two aspects of the disclosure are operablyconnected, the two aspects may or may not be directly connected unlessotherwise specified. For example, the lead screw nut 670 and the hollowdrive shaft may or may not be directly connected. In the examples ofFIGS. 4-8, the lead screw nut 670 and the hollow drive shaft areoperably connected through the gearbox 700 because rotation of thehollow drive shaft by the motor 630 also causes the lead screw nut 670to rotate via the gearbox 700. As discussed, this rotation engages thelead screw 620 such that the lead screw 620 moves proximally or distallywithin an autoinjector and within the hollow centers of the gearbox 700and/or the hollow drive shaft of the motor 630. Accordingly, two aspectsof the various embodiments described herein as operably connected may bedirectly connected or may be connected by an intermediate aspect of theembodiments discussed herein.

In one instance, the lead screw nut 670 rotates in a direction thatcauses the lead screw 620, and thus the plunger head driver 610, to movein a proximal direction toward the gearbox 700 and the motor 630. It isdesirable to cause the plunger head driver 610 not to move into the leadscrew nut 670 however. Accordingly, the lead screw 620 can have flatsurfaces at a distal end of the lead screw 620, just before the plungerhead driver 610 at the distal-most end of the lead screw 620. Inaddition, the distal-most end of the gearbox 700 has at least two flatsurfaces that can contact the at least two flat surfaces of the leadscrew 620. Thus, if the lead screw 620 moves far enough in a proximaldirection, the flat surfaces of the gearbox 700 contact the flatsurfaces of the lead screw 620 preventing further rotational motion ofthe lead screw 620 (at least in a direction that would cause the leadscrew 620 to move further in the proximal direction). This keeps theplunger head driver 610 from entering inside the lead screw nut 670, andalso ensures that the lead screw nut 670 stays engaged with the leadscrew 620. In various embodiments, similar surfaces may also beimplemented at a proximal end of the lead screw 620 and motor 630 toprevent the lead screw from moving past the proximal end of the motor630. In other embodiments, such similar surfaces may be implementedsomewhere between the proximal end of the motor 630 and the distal-mostend 675 of the gearbox 700, to prevent an end of the lead screw 620 fromreaching the lead screw nut 670 and potentially causing the lead screwand the lead screw nut 670 from coming disengaged. Other methods forpreventing the lead screw 620 from moving further than desired may alsobe utilized. For example, a position of the lead screw 620 and/or theplunger head driver 610 may be tracked. This information can be utilizedto ensure that signals sent to the motor never cause the lead screw 620to move farther than desired in one or more direction.

In some embodiments, the lead screw 620 may further include surfacesthat engage with surfaces of a gearbox 700 or surfaces of othercomponents to prevent the lead screw 620 from rotating. By preventingrotation of lead screw 620, but still allowing it to move axially, therotational torque of the lead screw nut 670 and/or one or more gears ofgearbox 700 is translated into linear force exerted by the lead screw620. In these embodiment, the surfaces of lead screw 620 and/or surfacesof a gearbox 700 or surfaces of other components may be in any shape. Insome embodiments, the lead screw 620 and gearbox 700/other componentsmay each include one surface for preventing the lead screw 620 frommoving in a first direction. In some embodiments, the lead screw 620 andgear box 700/other components may each include another surface forpreventing the lead screw 620 from moving in a second direction oppositeto the first direction.

Referring now to FIG. 5, the motor 630 includes a rotor 650 and coilwindings. The coils get energized through the motor base via acommutator ring 660 through commutator brushes 640, and held in place bythe back plate 645. The motor rotor 650 is held in place with a rotorspacer 655 and motor bearings 665. A stator 680 includes two or moresolid-state magnets. In various embodiments, other types of motors thanthe one shown in FIG. 5 may be utilized with the autoinjectors discussedherein.

Referring now to FIGS. 5-7, the gearbox 700 includes a planetary gearset comprising at least one stage of a sun gear 710, planetary gears720, a planetary carrier 730, and a ring gear 740. For multiple stages,the planetary carrier 730 is rigidly attached to the next stage sun gear710. The forward-most planetary carrier 730 is rigidly attached to thelead screw nut 670. The ring gear 740 may be hobbed into the gearboxhousing 705. The lead screw nut 670 exerts force on one or more bearings750 providing linear and radial rigidity. In various embodiments, otherconfigurations of gearboxes may be utilized with the variousautoinjectors discussed herein. In some embodiments, no gearbox mayutilized, and a drive shaft of the motor 630 may be connected directlyto the lead screw nut 670. In some embodiments, the drive shaft of themotor 630 may include the lead screw nut 670.

FIG. 8 shows a cross section of a linear actuator 600 and with regardsto FIGS. 4-7 above. As can be seen in FIG. 8, the lead screw 620 passesthrough a hollow drive shaft of the motor 630 and a hollow center of thegearbox 700. Advantageously, this allows for a small cylindrical packagethat can fit well into an autoinjector, and the linear actuator can beutilized to implement several different functions of the autoinjectorsas described herein.

Needle Cap Removal

FIG. 9 is a sectioned perspective view of a reusable autoinjector basein accordance with the disclosed embodiments the disclosed embodiments.The reusable autoinjector base shown in FIG. 9 includes a claspmechanism 805, a backplate 810, a sensor 830, and a housing 880. Alsoshown in FIG. 9 are embedded systems 701, a linear drive mechanism 600,a lead screw 620, and a plunger head driver 610. The linear drivemechanism 600 includes a motor with a hollow drive shaft. For example,the linear drive mechanism 600 may be the drive mechanism describedabove with respect to FIGS. 4-8 above. The pod clasp mechanism 805includes a latch lock 870, a latch lock center 875, a latch lock spring820, and a base latch 850, the functions of each of which will bedisclosed in more detail below.

In the distal-most position of the clasp mechanism 805, the latch lockspring 820 is decompressed, rotating the latch lock 870, and locking thepod clasp mechanism to the housing 880. This prevents the claspmechanism 805 from moving axially within the housing. When the latchlock 870 is rotated, the clasp mechanism 805 becomes unlocked from thehousing 880, allowing for axial movement of the clasp mechanism 805within the housing 880. This feature is described in more detail herein,for example with respect to FIGS. 19 and 20 below.

Upon insertion of a dose cassette into the autoinjector base, the baselatch 850 is pushed radially outwards (shown, e.g., in greater detail inFIG. 16), allowing the dose cassette to pass the base latch 850, and fixto a ledge of a dose cassette (e.g., ledge 109 shown in FIG. 11). Inaddition, the backplate 810, which is biased distally via a backplatespring 815, is pushed back by the dose cassette being inserted,compressing the backplate spring 815 (e.g., as shown in FIG. 17). Whenthe dose cassette is in the locked position, an RFID reader 750 canreads data from a dose cassette RFID tag (e.g., the RFID tag 104 in FIG.12). This data may include information such as information aboutmedicament stored in a dose cassette, a date of manufacture of themedicament and/or the dose cassette, a unique identifier of the dosecassette used to track the dose cassette, a dosage amount in the dosecassette, and/or any other information.

Once the dose cassette is latched and fixed into the autoinjector base,the linear drive mechanism 600 moves the lead screw 620 and plunger headdriver 610 proximally (i.e., the plunger head driver 610 is moved towardthe motor 630). The plunger head driver 610 engages with the latch lockcenter 875, moving the latch lock center 875 and the plunger head driver610 in unison in a proximal direction (i.e., toward the motor 630). Thelatch lock center 875 is attached to the latch lock 870, so the motionof the latch lock center 875 rotates the latch lock 870, disengaging theclasp mechanism 805 from the housing 880, allowing the clasp mechanism805 to move proximally within the housing 880. This process is describedin further detail below with respect to FIGS. 15-20 below.

Once the latch lock 870 is unlocked, the entire clasp mechanism 805 canbe moved proximally within the housing 880, including the base latch 850that has locked in a dose cassette. Accordingly, the dose cassette willalso move proximally within the housing 880 as the plunger head driver810, the latch lock center 875, the latch lock 870, and the base latch850 move proximally (i.e., toward the motor 630) within the housing 880.Accordingly, a rigid needle cap of the dose cassette can thenmechanically engage with the sensor 830 while the rest of the dosecassette moves proximally along with the clasp mechanism 805, removingthe needle cap. This process is described in further detail with respectFIGS. 19-23. In some embodiments, the needle cap may mechanically engagewith a portion of the housing 880 instead of, or in addition to thesensor 830. In some embodiments, the sensor 830 is considered to be apart of the housing 880 or is incorporated into the housing 880, suchthat the mechanical engagement that removes the needle cap is betweenthe needle cap and the housing 880.

After the needle cap of the dose cassette is removed, the lead screw 620and plunger head driver 610 return to the previous position (which issimilar to the position shown in FIG. 9). Thus, the latch lock spring820 rotates the latch lock 870 back into a locked position, locking theclasp mechanism 805 into a position such that it cannot move axiallywithin the housing 880. This process is discussed further with respectto FIGS. 21-24. The plunger head driver 610 can then move distally(i.e., away from the motor 630) to commence needle insertion, drugdelivery, and needle retraction within a dose cassette as describedherein including with respect to FIGS. 11-14 and 26.

Dose Cassette Removal

After needle insertion, drug delivery, and needle retraction, theplunger head driver 610 returns back to a position similar to that shownin FIG. 9. A dose cassette can then be ejected from the autoinjectorbase. To eject the dose cassette, the lead screw 620 and plunger headdriver 610 move proximally (i.e., toward the motor 630 within thehousing 880) along with the clasp mechanism 805 in a similar way asduring the needle cap removal. However, for dose cassette ejection, theclasp mechanism 805 moves to a point beyond the previous position atwhich the needle cap was removed. This point may be a proximal-mostposition of the clasp mechanism 805 and plunger head driver 610. Thebase latch 850 then mechanically engages with the housing 880 via a rampon the base latch 850, causing the base latch to move radially outwardsand unlatch a dose cassette. In other words, the base latch 850 isremoved from a ledge of a dose cassette. Once the base latch 850 is notsecuring a dose cassette, the tension in the backplate spring 815decompresses, pushing the backplate 810 and a dose cassette distally,expelling the dose cassette from the autoinjector base through anopening at the distal end of the autoinjector base through which thedose cassette was originally inserted (e.g., at an end of theautoinjector base where the sensor 830 is located). The backplate 810 isnot connected to any components of the clasp mechanism 805 (e.g., thebase latch 850, the base latch lock 870, the latch lock center 875, andthe latch lock spring 820). Accordingly, the backplate 810 can moveindependently of the clasp mechanism 805 to eject a dose cassette whenthe back plate spring 815 decompresses. By pulling the clasp mechanism805 back to a proximal-most position as described above while the baselatch 850 still secures a dose latch, the back plate spring can becompressed to store energy significant enough to eject the dose cassettecomplete from the autoinjector base once the base latch 850 no longersecures the dose cassette within the housing 880. This process isdescribed herein further with respect to FIGS. 27-30. A user can check adose cassette (e.g., viewing window 107 of FIG. 11) after it has beenejected to ensure the medicament in the dose cassette was expelledproperly and/or in its entirety.

The lead screw 620 and plunger head driver 610 can then move distally,back to a previous position as shown in FIG. 9, locking the pod claspmechanism 805 to the housing 880, which is a reset position of theautoinjector base. That is, the autoinjector base is now configured toreceive a subsequent dose cassette and repeat the various processesdescribed herein to inject a user and dispense a medicament.

FIG. 10 is a cross-section view of the reusable autoinjector base 1000in accordance with the disclosed embodiments. In particular, FIG. 10shows another view of the aspects of an autoinjector base as describedabove with respect to FIG. 9. It shows the reusable autoinjector base1000 without a dose cassette. It also includes the linear actuator 600as described herein having a hollow drive shaft and gearbox 700 with ahollow center that allows the lead screw 620 to pass through.

The lead screw 620 includes a plunger head driver 610 that has adiameter wider than an opening in the latch lock center 875. In thisway, when the linear actuator 600 rotates the lead screw 620 to move theplunger head driver 610 proximally (i.e., toward the motor 630) withinthe housing 880 of the reusable autoinjector base 1000, the plunger headdriver 610 mechanically engage with the opening of the latch lock center875, such that the latch lock center 875 can be pulled in a proximaldirection (i.e., toward the motor 630) by the plunger head driver 610.This proximal movement creates a force that overcomes a bias of thelatch lock spring 820 to rotate the latch lock 870 as described herein,unlocking the latch lock 870 from the housing 880 and allowing the claspmechanism 805 to move axially within the housing. Because the plungerhead driver 610 can continue to mechanically engage with the latch lockcenter 875, which is part of the clasp mechanism 805, the plunger headdriver 610 can move further in a proximal direction within the housing880 to implement various functionalities described herein, includingremoval of a needle cap and ejecting a dose cassette. When the plungerhead driver 610 is in a more distal position away from the latch lockcenter 875 as shown in FIG. 10, the plunger head driver 610 is notengaged with the latch lock center 875. In this way, the plunger headdriver can move into a dose cassette to implement needle insertion, dosedelivery, and needle retraction as described herein. Accordingly, thesingle linear actuator 600 with the lead screw 620 and the plunger headdriver 610 can be advantageously utilized to implement each of lockingof an inserted dose cassette, removal of a needle cap of the dosecassette, needle insertion into the user of a needle in the dosecassette, dosage delivery of a medicament stored in the dose cassette,retraction of the needle back into the dose cassette, and ejection ofthe spent dose cassette as described herein.

Needle Insertions/Retraction and Medication Administration

FIG. 11 is a perspective view of a dose cassette in accordance with thedisclosed embodiments. FIG. 12 is a sectioned perspective view of a dosecassette in accordance with the disclosed embodiments. The dose cassetteincludes an outer secondary container 110, the primary container 105filled with medicament, a primary container carrier 106, at least onespring 103 to bias the primary container, a needle cap 108, a lockingmechanism 101 to fix the primary container 105 within the dose cassetteprior to activation, a latching mechanism 102 to release the primarycontainer from this fixed position via the linear actuator, a primarycontainer viewing window 107, and an RFID tag 104 to storedrug/medicament information. The dose cassette also includes a ledge 109that allows the base latch of an autoinjector to lock the dose cassettein place. The primary container 105 may be biased distally by the spring103. During transportation and storage, the dose cassette needleinsertion and retraction latching mechanism 102 is locked due to theposition of the needle cap 108, which secures the locking mechanism 101.The locking mechanism 101 is biased distally and mechanically engaged(or “interferes”) with the latch mechanism 102 when the needle cap 108is in place, such that the latching mechanism 102 cannot move to unlatchthe primary container 105 whenever the locking mechanism 101 and theneedle cap 108 are in place. The locking mechanism 101 prevents theneedle from accidentally being actuated during storage or transportationof the dose cassette, as well as when the dose cassette is being handled(e.g., when the dose cassette is being inserted into an autoinjector).Because the retraction latching mechanism 102 is biased by the spring123, the spring could potentially become compressed, for example, if thedose cassette is dropped. If the spring 123 is compressed enough, theretraction latching mechanism 102 could become disengaged with thehousing of the dose cassette, causing the needle to move. The lockingmechanism ensures that such an event does not happen.

FIG. 13 is a sectioned perspective view of a portion of a dose cassettein accordance with the disclosed embodiments. The portion of the dosecassette in FIG. 13 shows a close up of the sectioned perspective viewof the dose cassette of FIG. 12. The needle insertion and retractionlatching mechanism 102 is biased radially towards the walls of thesecondary container via a spring 123. Removing the needle cap 108 allowsthe lock mechanism 101 to be deactivated, such that the retractionlatching mechanism 102 can move radially within the dose cassette. Thespring 123 bias is overcome when the plunger head driver 610 pushes thelatch off the secondary container housing ledge 122. The plunger headdriver 610 pushes the retraction latching mechanism 102 via a ramp 115,visible in FIG. 14. In an alternative embodiment, the plunger headdriver may have a ramp to push the retraction latching mechanism. Ineither embodiment, the plunger head driver and retraction latchingmechanism are configured such that an axial movement of the plunger headdriver can cause the retraction latching mechanism to move radially.

With the spring 103 biased distally, a rapid needle insertion is enactedwhen the latch of the retraction latching mechanism 102 is pushed offthe secondary container housing ledge 122. In other words, when theretraction latching mechanism 102 no longer mechanically engages withthe secondary container housing ledge 122, the spring 103 that iscompressed pushes rapidly out of the dose cassette housing. The spring103 also continues to bias the primary container 105 after the needlehas been inserted so that the needle stays in position while amedicament is administered. The needle outside of the housing can beseen in FIGS. 25 and 26. The linear actuator 600 proceeds furtherdistally beyond the retraction latching mechanism 102 to expelling themedicament. The dose is expelled by the plunger head driver 610 pushinga plunger head 120 of the dose cassette (the plunger head 120 is shownin FIG. 14). The needle may be inserted to a particular depth based onhow the dose cassette is configured. For example, the primary container105 may be configured with a wider diameter at the proximal end so thatit cannot extend past a specific point, such as near the ledge 109 wherethe wider diameter portion of the primary container 105 may mechanicallyengage with the housing of the dose cassette. In another example, thedistal end of the housing of the dose cassette may narrow such that theprimary container 105 cannot move past that section of the housing.Accordingly, a needle may be controlled to only extend a predeterminedamount outside of the dose cassette and/or autoinjector base. The spring103 also keeps the primary container 105 and the needle biased distally

When the full dose is expelled, the linear actuator moves proximallyback to a home position, such as the position. During the return stroke,the plunger head driver 610 is coupled to the retraction latchingmechanism 102, pulling the primary container assembly (the lockingmechanism 101, the retraction latching mechanism 102, the primarycontainer 105, primary container carrier 106) proximally into the dosecassette. This occurs because a surface opposite the ramp 115 (on adistal side of the retraction latching mechanism) mechanically engageswith the plunger head driver 610 when it moves proximally through thedose cassette after the needle has been inserted and the dose has beenexpelled. Accordingly, the primary container assembly can moveproximally and pull the needle out of the user and back into the dosecassette as the plunger head driver 610 moves proximally through thedose cassette.

As the plunger head driver 610 and the retraction latching mechanism 102reaches the proximal-most end of the dose cassette, the latchingmechanism 102 is pushed outward by a ramp 121 of the housing of the dosecassette, disengaging with the plunger head driver 610 so that theplunger head driver 610 and the retraction latching mechanism 102 becomedecoupled. The ledge 122 also has a ramp so that the latching mechanismcan move past the ledge on the return stroke as well. The spring bias ofboth springs 123 and 103 reorient the primary container assembly backinto their initial position once the plunger head driver 610 is releasedfrom interfering with the latching mechanism 102. In the initialposition, as shown in FIGS. 12-14, the latching mechanism 102 rests onthe dose cassette ledge 122. This secures the used needle within thedose cassette, and the dose cassette can then be safely ejected from anautoinjector without having an exposed needle.

FIG. 14 is a cross section view of a dose cassette in accordance withthe disclosed embodiments. The dose cassette is similar to the dosecassette described above with respect to FIGS. 11-13, except the spring103 is in a different location within the dose cassette. FIG. 14 showsthe latching mechanism 102 that has a ramp 115. The ramp 115 is actuatedby the plunger head driver 610, unlatching the latching mechanism 102from the housing/outer container of the dose cassette at the ledge 122.FIG. 14 also shows the RFID tag 104 that can be read by an RFID reader,such as the RFID reader 750 of FIG. 9. FIG. 14 also shows the plunger120 of the dose cassette that can be actuated by the plunger head driver610 of an autoinjector to expel a dosage of medicament to a user.

Although the mechanisms for needle actuation described above are withrespect to a needle in a disposable dose cassette, the aspects of thedose cassette can be implemented in a reusable autoinjector as well,whether the reusable autoinjector uses dose cassettes or not. That is,methods and aspects for securing, actuating, and retracting the needleas described herein are not limited to disposable dose cassettes.Accordingly, rapid needle insertion can occur as a feature of a primarydrive mechanism used to deliver medicament in any type of injector,other embodiments of which are described below.

In various embodiments, during a resting state, the needle is retractedwithin the injector unit (a home position). A primary container is fixedto a primary container carrier, which is fixed to one end of a tensionspring. The primary container carrier can move axially within the unit.In the home position, the spring is elongated, producing a force in thedistal direction of the device. This position is maintained via alatching mechanism. The latching mechanism is spring biased toward aledge. The ledge is perpendicular to the axial motion of the primarycontainer carrier and rigidly attached to the unit. In variousembodiments, the latching mechanism may move linearly or rotationally,but in either method the latching mechanism travels perpendicular to theprimary axis and moves such that the latching mechanism no longermechanically engages with the ledge. Accordingly, the latching mechanismis shaped such that the linear or rotational movement will cause thelatching mechanism to disengage with the ledge. The ledge is preceded bya ramp, allowing the latching mechanism to slide up the ramp, againstthe spring force, and secure to the ledge.

To release the latch from the ledge, a linear actuator provides a rampand hook. The linear actuator also provides a ledge, which is largerthan the one rigidly attached to the unit. As the ramp moves distally,it contacts a section of the latch, sliding the latch free from theledge. In another embodiment, a ramp may be on the latch instead of orin addition to the ramp on the linear actuator. In any case, theengagement of the linear actuator translates motion from the linearactuator into motion of the latch in a perpendicular direction to themotion of the linear actuator. The movement of the latch releases thetension spring, rapidly driving the primary container carrier distally.The carrier is stopped at a pre-determined distance via a mechanicalbarrier, depending on needle depth requirements.

As the linear actuator proceeds distally, expelling the medicament, theramp and hook push the latching mechanism aside, and then proceedsbeyond the contact point of the latch to engage a plunger. When thelinear actuator retracts proximally within the device, the latchingmechanism attaches to the hook on the linear actuator. The linearactuator overcomes the spring force, and the two components movedistally together. Because the hook ledge is greater than that of theledge on the unit, it allows the latching mechanism to slide over theramp while remaining fixed to the hook on the linear actuator. A secondramp immediately proceeds the first, which is larger than the hookledge. This causes the latch to be released from the hook. Upon releasefrom the hook, the latch and primary container carrier springs returnand secure the primary container to the home position ledge.

To prevent misfires if the unit is dropped or misused, additional designfeatures may be included. For example, an embodiment includes a lockwhich mechanically engages with the latching mechanism. This lock isbiased in place via the needle shield. When the lock is in place, thelatching mechanism cannot be removed from the ledge, ensuring the springforce cannot be overcome if dropped or mishandled. Upon removal of theneedle cap, the lock pulls away from the latching mechanism and thelatch can then be released from the ledge.

In some embodiments, a second ramp and hook are on the linear actuatordistally located from the first ramp and hook. In this embodiment, ifthe latch detaches from the ledge accidentally, the primary containercarrier proceeds to engage and get caught on the secondary hook. Thesecondary hook is located such that the needle is still distally locatedwithin the device to prevent a needle stick injury. Sensors within thedevice can detect this anomaly and reset the latch by moving the linearactuator distally, and replacing the latch onto the ledge.

This secondary ramp and hook can also provide a way to remove a rigidneedle shield. As the first ramp removes the latch from the ledge, theprimary container carrier proceeds to the second hook. Meanwhile, thispushes the rigid needle shield through an elastomeric iris. As thelinear actuator returns distally, the iris affixes to the needle shield,pulling it from the syringe. The linear actuator then proceeds distallyand replaces the latch onto the ledge.

FIG. 15 is a sectioned perspective view of a reusable autoinjector baseand a dose cassette 100 just prior to the dose cassette being insertedinto the reusable autoinjector base in accordance with the disclosedembodiments. FIG. 15 shows a dose cassette 100, a backplate 810, aplunger head driver 610, a base latch 850, and a latch lock 870. In FIG.15, the dose cassette 100 is about to be inserted into the autoinjectorbase. The dose cassette 100 may be a dose cassette such as the onedescribed above with respect to FIGS. 11-14. The autoinjector base maybe an autoinjector base such as the one described above with respect toFIGS. 9 and 10 having a linear actuator such as the one described abovewith respect to FIGS. 4-8. FIGS. 16-30 discussed below demonstrate thevarious states of a dose cassette and autoinjector according to anembodiment of the present technology.

FIG. 16 is a sectioned perspective view during an insertion of a dosecassette into a reusable autoinjector base in accordance with thedisclosed embodiments. FIG. 16 shows the dose cassette 100 moving intothe reusable autoinjector base. As the dose cassette is inserted, thebase latch 850 moves radially toward the housing of the autoinjectorbase. This allows the dose cassette to be fully inserted into theautoinjector base. The base latch 850 includes a ramp 851 that engageswith the dose cassette as the dose cassette is inserted. Thisinteraction pushes the base latch 850 outward radially allowing the dosecassette to continue to move axially within the autoinjector base.

FIG. 17 is a sectioned perspective view of a dose cassette locked into areusable autoinjector base in accordance with the disclosed embodiments.FIG. 17 shows the dose cassette after it has been pushed into theautoinjector base. A portion of the base latch 850 slides past the ledge109 into a space where the dose cassette has a smaller diameter than therest of the dose cassette. A locking surface 852 on the base latch 850mechanically engages with a surface of the ledge 109 to lock the dosecassette in place with respect to the clasp mechanism of theautoinjector. In this way, as described herein, the dose cassette issecured within the autoinjector but can also be moved radially withinthe autoinjector along with the clasp mechanism. FIG. 17 also shows asensor 830 and a needle cap 108. In addition, once fully inserted, aproximal end of the dose cassette bumps up against a backplate 810,causing a backplate spring 815 to be compressed. This spring biases thebackplate 810 against the dose cassette, which pushes up against thebase latch 850 such that the dose cassette is secured within theautoinjector base.

FIG. 18 is a cross section view of a dose cassette locked into areusable autoinjector base in accordance with the disclosed embodiments.The dose cassette is shown as being fully inserted in the autoinjectorbase, and the base latch 850 is in position to secure the dose cassette.At this point, no injection has taken place and the needle cap of thedose cassette is still covering the needle in the dose cassette. Aplunger drive unit 610 is also shown engaging the latch lock center 875.As described herein, this allows the plunger drive unit 610 to rotatethe latch lock 870 and move the clasp mechanism and dose cassetteaxially within the autoinjector base. FIG. 18 also shows how the RFIDtag 104 of the dose cassette can align with the RFID tag reader 750 sothat the information stored on the RFID tag 104 can be read.

FIG. 19 is a sectioned perspective view of a dose cassette within ahousing of a reusable autoinjector base in accordance with the disclosedembodiments. FIG. 19 shows that a plunger drive unit has started to pullthe latch lock center proximally within the housing, causing the latchlock 870 to rotate around a hinge 871. This causes a locking arm of thelatch lock 870 to move out of a locking space 872 and into an unlockedspace 873. Once the locking arm of the latch lock 870 is in in theunlocked space 873, the clasp mechanism including the latch lock 870 andthe base latch 850 can move proximally within the housing as shown inFIGS. 20-23. This in turn also moves the dose cassette because the baselatch 850 secures the dose cassette.

FIG. 20 is a sectioned perspective view of a needle cap of a dosecassette beginning to be removed in accordance with the disclosedembodiments. FIG. 20 shows the clasp mechanism including the base latch850 and the latch lock 870 having moved proximally within theautoinjector, such that needle cap 108 begins to be separated from thedose cassette because of mechanical engagement with a distal end of thehousing. In this case, the distal end of the housing includes a sensor830, but other embodiments may not have a sensor at the distal end ofthe housing where the needle cap mechanically engages with the housing.In this example, the sensor 830 is a proximity sensor that can detect apresence of the needle cap. Once the needle cap is fully inserted theautoinjector, the system may determine that a needle cap removal processmay begin based on a signal from the sensor 830 indicating that a needlecap is present. As described herein, the needle cap 108 has a diameterthat is larger than the diameter of the dose cassette. In this way, thedose cassette can slide into the housing but the needle cap 108mechanically engages with the housing of the autoinjector base. FIG. 20also shows that the baseplate 810 moves proximally along with the dosecassette, compressing the spring 815.

FIG. 21 is a sectioned perspective view of a needle cap of a dosecassette contacting a sensor of a reusable autoinjector base inaccordance with the disclosed embodiments. FIG. 21 is similar to FIG. 20but shows the sensor 830 and a spring 831 that biases the sensor 830distally. When the dose cassette is pulled backward, the needle cap 108mechanically engages with the sensor 830, causing it to move proximallyas shown in FIG. 21. This spring can help the needle cap 108 be removedbriskly once it has been pushed far enough out of the dose cassette.

FIG. 22 is a sectioned perspective view of a needle cap of a dosecassette being removed in accordance with the disclosed embodiments.Once the needle cap is removed as shown in FIG. 22, the spring 831pushes the sensor 830 back forward. Accordingly, as shown in FIGS.19-23, an autoinjector with a housing for disposable dose cassettes canbe loaded. The dose cassette includes a primary container and needle, asecondary container, and a needle cap, the needle cap including a needleshield connected to a rigid base with a diameter larger than thesecondary container of the dose cassette. When the dose cassette isloaded into the autoinjector housing, the outer edge of the rigid basemakes contact with the pressure sensor surrounding the distal end of thehousing. The autoinjector detects the presence of the needle cap viacontact between the outer edge of the rigid base and the pressure sensoron the distal end of the housing. The autoinjector moves the dosecassette proximally within the housing of the autoinjector, separatingthe needle cap from the dose cassette when the proximal movement of theneedle cap is impeded by contact between the outer edge of the rigidbase and the pressure sensor on the distal end of the housing. Theautoinjector then detects the absence of the needle cap via a loss ofcontact between the rigid base and pressure sensor when the needle capis separated from the dose cassette. The autoinjector can then beactivated for injection once the pressure sensor loses contact with theouter edge of the rigid base, confirming the needle cap has been removedfrom the dose cassette.

FIG. 23 is a cross section view of a needle cap of a dose cassette beingremoved in accordance with the disclosed embodiments. It shows the dosecassette 108 beginning to be removed, similar to FIGS. 20 and 21, andshows the latch lock 870 in a rotated, unlocked state that allows forthe clasp mechanism to move axially within the housing, so that the dosecassette can be moved for needle cap removal.

FIG. 24 is a sectioned perspective view of a dose cassette locked inplace in advance of a needle protruding from the dose cassette inaccordance with the disclosed embodiments. The needle cap in FIG. 24 hasbeen removed, and the latch lock 870 has returned to a locked state, asthe locking arm of the latch lock 870 has moved back into the lockingspace 872 and out of the unlocked space 873.

FIG. 25 is a sectioned perspective view of a needle protruding from adose cassette in accordance with the disclosed embodiments. The plungerhead driver of the linear actuator can proceed into the dose cassette toactuate needle insertion as described herein. FIG. 25 shows a needle 130extending from the autoinjector base.

FIG. 26 is a cross section view of a needle protruding from a dosecassette in accordance with the disclosed embodiments. The lead screw620 in FIG. 26 can be seen extending into the dose cassette to actuatethe needle 130 insertion. Although the plunger head driver 610 has notyet engaged a plunger to deliver the medicament, the plunger head driver610 can move distally even further to engage the plunger and deliver themedicament being stored in the primary container 105 through theextended needle 130. FIG. 26 also shows the latch lock 870 in a lockedstate.

FIG. 27 is a sectioned perspective view of a dose cassette beingunlocked from a reusable autoinjector base in accordance with thedisclosed embodiments. In FIG. 27, the latch lock 870 is again rotatedaround a hinge 871 when the linear actuator pulls the plunger headdriver 610 proximally so that it mechanically engages with the latchlock center 875. This again causes the locking arm of the latch lock 870to move into the unlocked space 873. In addition, the base latch 850,the dose cassette, and the backplate 810 are also moved proximallywithin the housing. In FIG. 27, the latch lock 870, the base latch 850,the dose cassette, and the backplate 810 are moved proximally furtherthan they were for the needle cap removal as shown in FIGS. 19-23. Thiscauses a ramp 853 of the base latch 850 to mechanically engages withpart of the housing of the autoinjector to unlatch the base latch 850.During needle cap removal, the ramp 853 does not mechanically engageswith the housing, so the dose cassette stays secured by the base latch850. This is why the base latch 850 is moved further in a proximaldirection in order to unlatch the dose cassette after injection. FIG. 27also demonstrates how this mechanical engagement between the ramp 853and the housing causes the locking surface 852 of the base latch 850 tobecome disengaged with the ledge 109, thereby unlatching the dosecassette from the autoinjector base. The movement of the backplate 810as the dose cassette is pulled back also further compresses the spring815, storing compression energy that is used to eject the dose cassetteas described herein (and shown for example in FIGS. 29 and 30).

FIG. 28 is a cross section view of a dose cassette being unlocked from areusable autoinjector base in accordance with the disclosed embodiments.FIG. 28 shows the mechanical engagement of a ramp of the base latch 850with the housing of the autoinjector, causing the base latch 850 to moveradially away from the dose cassette and disengage from the ledge 109.FIG. 28 also shows how the plunger head driver 610 is engaged with thelatch lock center 875 to pull each of the latch lock center 875, thelatch lock 870, the base latch 850, and the dose cassette proximally toa position further proximal than the position at which the needle capwas removed (as shown for example in FIG. 23). Also shown is how theneedle has been pulled back into the dose cassette housing afterinjection.

FIG. 29 is a sectioned perspective view of a dose cassette 100 beingejected from a reusable autoinjector base in accordance with thedisclosed embodiments. FIG. 30 is a sectioned perspective view of anejected dose cassette 100 in accordance with the disclosed embodiments.After the base latch 850 becomes disengaged from the dose cassette 100as described above with respect to FIGS. 27 and 28, the dose cassette100 is ejected as a result of the spring 815 pushing the backplate 810distally, which also then pushes the dose cassette 100 distally. Asdescribed above, the needle is withdrawn back into the dose cassettebefore ejection such that the dose cassette may be safely disposed ofAfter full ejection as shown in FIG. 30, the autoinjector is returnedback to a position such as that shown in FIGS. 9 and 15, so that it canreceive a subsequent dose cassette. To do so, the plunger head driver610 moves proximally, allowing the latch lock to be pushed proximally bythe spring 820 and return to a locked position.

FIG. 31 is a flow diagram illustrating a method 3100 for utilizing alinear actuator with a hollow drive shaft in accordance with thedisclosed embodiments. In various embodiments, fewer, additional, and/ordifferent operations may be performed. Also, the use of a flow diagramis not meant to be limiting with respect to the order of operationsperformed unless otherwise noted. In an operation 3105, a hollow driveshaft is rotated by a motor. The hollow drive shaft and motor may besimilar to those described herein, such as with respect to FIGS. 4-8above. In an operation 3110, a lead screw nut is rotated in response torotation of the hollow drive shaft. The lead screw nut is operablyconnected to the hollow drive shaft. The lead screw nut may be connectedto the hollow drive shaft directly or through a gear box.

In an operation 3115, the lead screw is moved in response to therotation of the lead screw nut. The lead screw is operably connected tothe lead screw nut. In particular, the threads of the lead screw engagewith the lead screw nut so that the lead screw can move axially withinthe lead screw nut. This can therefore translate rotational motion fromthe motor into linear motion of the lead screw. As described herein, therotation of the lead screw nut can also include exerting, from thehollow drive shaft, a rotational force on the lead screw nut via a gearbox operably connected to the hollow drive shaft and the lead screw nut.As described herein, the lead screw is configured to pass through all orat least part of the hollow drive shaft. The gear box may also include ahollow gear box opening, that allows the lead screw to pass through allor part of the hollow gear box opening. This hollow gear box opening isaligned with the hollow drive shaft as described herein. The lead screwmay pass through an entire length of each of the hollow gear box openingand the hollow drive shaft, even extending outside of the hollow gearbox opening and hollow drive shaft combined.

As described herein, the lead screw can have a plunger head driver atits distal end. Therefore, using rotation of the motor causing movementof the lead screw, the various methods and systems disclosed herein canbe practiced, including, e.g., automated needle cap removal, automatedrapid needle insertion, medicament expulsion, automated dose cassetteejection, and any combination thereof. The motor may also be controlledby a controller that can send signals to the motor to control aspects ofthe motor such as speed at which to rotate, which direction to rotate,etc. In this way, the motor can be controlled to implement the variousmethods and systems described herein.

FIG. 32 is a flow diagram illustrating a method 3200 for removing aneedle cap from a dose cassette in accordance with the disclosedembodiments. In various embodiments, fewer, additional, and/or differentoperations may be performed. Also, the use of a flow diagram is notmeant to be limiting with respect to the order of operations performedunless otherwise noted. In an operation 3205, a dose cassette isreceived into a housing. The dose cassette includes an outer containerand a needle cap having a base with a diameter larger than the outercontainer. In an operation 3210, the dose cassette is secured within thehousing using a clasp mechanism as described herein. Although specificclasp mechanisms are described above, any mechanism suitable forsecuring the dose cassette within the housing may be utilized.

In an operation 3215, the dose cassette is moved proximally within thehousing after the dose cassette is secured within the housing. In anoperation 3220, a presence of the base of the needle cap at the distalend of the housing is sensed. In some embodiments, the presence of theneedle cap may not be detected. Once the presence of the needle cap issensed, the needle cap is separated from the dose cassette because ofmechanical engagement between a distal end of the housing and the needlecap in an operation 3225. In some embodiments, the needle cap may beremoved only after the needle cap is sensed.

In an operation 3230, it is determined that the needle cap has separatedfrom the dose cassette. This sensing may utilize the same sensor used inthe operation 3220, or may utilize a different sensor. The sensor(s)used to determine presence or absence of a needle cap may also beutilized to determine the presence of skin after the needle cap isremoved. In this way, an autoinjector can determine that, after a needlecap is removed, the autoinjector is in proper position for an injection.In some embodiments, the autoinjector will not initiate the rapid needleinsertion disclosed herein unless skin is sensed. In an operation 3235,medicament of the dose cassette is delivered after determining that theneedle cap has separated from the dose cassette.

FIG. 33 is a flow diagram illustrating a method 3300 for ejecting a dosecassette from a reusable autoinjector base in accordance with thedisclosed embodiments. In various embodiments, fewer, additional, and/ordifferent operations may be performed. Also, the use of a flow diagramis not meant to be limiting with respect to the order of operationsperformed unless otherwise noted. In an operation 3305, a dose cassetteis received at a housing of an autoinjector device. In an operation3310, the dose cassette is secured within the housing using a baselatch. In an operation 3315, a black plate operably connected to aspring is moved. The back plate moves proximally within the housing uponreceipt of the dose cassette into the housing.

In an operation 3320, the spring is compressed as a result of theproximal movement of the back plate within the housing. In an operation3325, the dose cassette is moved by an actuator operably connected tothe base latch. The movement of the dose cassette and the base latch isproximally within the housing after the dose cassette is secured in thehousing. In an operation 3330, the dose cassette is ejected from thehousing in response to the proximal movement of the base latch and thedose cassette. The ejection of the dose cassette can be effected usingthe method 3400 described below with respect to FIG. 34.

FIG. 34 is a flow diagram illustrating a method 3400 for unlocking adose cassette from a reusable autoinjector base in accordance with thedisclosed embodiments. In various embodiments, fewer, additional, and/ordifferent operations may be performed. Also, the use of a flow diagramis not meant to be limiting with respect to the order of operationsperformed unless otherwise noted. In an operation 3405, the base latchmoves radially outwards because of proximal axial movement of the baselatch within the housing. The movement of the base latch causes the dosecassette to become unsecured within the housing. In an operation 3410,the spring attached to the backplate is decompressed in response to thedose cassette becoming unsecured. In an operation 3415, the back platemoves distally within the housing as a result of the decompression ofthe spring, wherein the movement of the back plate pushes the dosecassette out of a distal end of the housing.

As described herein the base latch may include a first ramp surface thatmechanically engages with the housing to cause the base latch to moveradially outwards upon the proximal movement of the dose cassette withinthe housing. The radially outward movement of the base latch causes alocking surface of the base latch to move out of contact with a ledge ofthe dose cassette. The base latch may also include a second rampsurface. During an insertion of the dose cassette, an outer container ofthe dose cassette mechanically engages with the second ramp surface andpushes the base latch radially outward until the locking surface of thebase latch reaches the ledge. Upon reaching the ledge, the distal end ofthe base latch moves radially inward into a space in the outer containerof the dose cassette at the ledge. The autoinjector may also include alatch lock operably connected to the base latch. The latch lock preventsthe base latch from moving axially within the housing while the dosecassette is being received into the housing.

The latch lock may be adjusted as described herein, in response to thesecuring of the dose cassette within the housing, such that the baselatch is permitted to move axially within the housing. This allows formoving the base latch and the dose cassette proximally within thehousing from a first position to a second position or a third position.At the first position the base latch secures the dose cassette withinthe housing upon full insertion of the dose cassette. At the secondposition a needle cap on a distal end of the dose cassette mechanicallyengages with a distal end of the housing such that the needle cap isremoved from the dose cassette. At the third position, the base latchmechanically engages with the housing and moves radially outwards tounlock the dose cassette as described herein. A first distance betweenthe first position and second position is less than a second distancebetween the first position and the third position.

A medicament stored within the dose cassette can be delivered after thedose cassette is secured within the housing. In some embodiments, thedose cassette may be ejected from the housing only after the medicamentis delivered.

FIG. 35 is a flow diagram illustrating a method 3500 for needleinsertion from a dose cassette in accordance with the disclosedembodiments. In various embodiments, fewer, additional, and/or differentoperations may be performed. Also, the use of a flow diagram is notmeant to be limiting with respect to the order of operations performedunless otherwise noted. In an operation 3505, a linear actuator is movedaxially within a housing to engage the linear actuator with a latchingmechanism operably connected to a primary container. The primarycontainer is operably connected to a needle and is configured to moveaxially within the housing. A first spring has a first end operablyconnected to the primary container and a second end operably connectedto the housing. An axis of the first spring may be oriented parallel toan axis in which the primary housing moves within the housing of anautoinjector base, so that energy stored by the spring can be applied tomove the primary housing. The latching mechanism is operably connectedto the primary container and is biased toward a ledge by a secondspring. The latching mechanism may also include a ramp oriented at anangle between an axis in which the linear actuator moves and a surfaceof the ledge perpendicular to the axis, such that when the linearactuator engages the latching mechanism, the latching mechanism moves ina plane perpendicular to the axis. In another embodiment, a distal endof the linear actuator includes a ramp oriented at an angle between anaxis in which the linear actuator moves and a surface of the ledgeperpendicular to the axis, such that when the linear actuator engagesthe latching mechanism, the latching mechanism moves in a planeperpendicular to the axis. The ledge is fixed with respect to thehousing. A surface of the ledge may be oriented perpendicular to theaxial direction of movement of the primary container within the housing.The second spring has a first end operably connected to the latchingmechanism and a second end operably connected to the primary container.An axis of the second spring may be oriented perpendicular to an axis inwhich the primary container moves within the housing of the autoinjectorbase, so that the latching mechanism can move perpendicular to themovement of the primary container based on energy stored in the secondspring. The primary container and the needle are fixed within thehousing based on mechanical engagement between the latching mechanismand the ledge before the linear actuator is engaged with the latchingmechanism.

In an operation 3510, the latching mechanism is moved in response toengagement of the linear actuator with the latching mechanism, such thatthe latching mechanism no longer mechanically engages with the ledge. Inan operation 3515, the primary container and the needle are moved inresponse to the movement of the latching mechanism. In particular, theprimary container and the needle are moved distally with respect to thehousing based on an energy stored in the first spring.

In an operation 3520, the linear actuator engages a plunger drive unitto dispense the medicament after the primary container and the needleare moved based on the energy stored in the first spring. In anoperation 3525, the latching mechanism is re-engaged by the linearactuator to retract the needle back into housing. In an operation 3530,the latching mechanism is re-engaged with the ledge to secure the needlewithin the housing. The housing may include a ramp configured to movethe latching mechanism such that the latching mechanism and linearactuator disengage based on distal movement of the linear actuator, andafter the needle is retracted back into the housing.

FIG. 36 is a block diagram illustrating an autoinjector computing device3600 and server computing device 3625 in accordance with the disclosedembodiments. The computing components shown in FIG. 36 may be used toimplement the various methods and systems disclosed herein with respectto autoinjectors. For example, the autoinjector may be controlled byinstructions stored on the memories of the server 3625 and or theautoinjector device 3600. In various embodiments, fewer, additionaland/or different components may be used in a system.

FIG. 36 illustrates the autoinjector device 3600 and a server 3625 thatmay be used in accordance with various embodiments. The autoinjectordevice 3600 includes a processor 3615 that is coupled to a memory 3605.The processor 3615 can store and recall data and applications in thememory 3605, including applications that control and track aspects ofautoinjectors as disclosed herein. The processor 3615 may also displayobjects, applications, data, etc. on the interface/display 3610. Theprocessor 3615 may also receive inputs through the interface/display3610. The processor 3615 is also coupled to a transceiver 3620. Withthis configuration, the processor 3615, and subsequently the first partyautoinjector device 3600, can communicate with other devices, such asthe server 3625 through a connection 3670.

The server 3625 includes a processor 3635 that is coupled to a memory3630. The processor 3635 can store and recall data and applications inthe memory 3630. The processor 3635 is also coupled to a transceiver3640. With this configuration, the processor 3635, and subsequently theserver 3625, can communicate with other devices, such as the first partyautoinjector device 3600 through a connection 3670.

The devices shown in the illustrative embodiment may be utilized invarious ways. For example, the connection 3670 may be varied. Theconnection 3670 may be a hard wired connection. A hard wired connectionmay involve connecting the devices through a USB (universal serial bus)port, serial port, parallel port, or other type of wired connection thatcan facilitate the transfer of data and information between a processorof a device and a second processor of a second device. In anotherembodiment, the connection 3670 may be a dock where one device may pluginto another device. While plugged into a dock, the autoinjector device3600 may also have its batteries charged or otherwise be serviced aswell as upload information about medicament deliveries to a server. Inother embodiments, the connection 3670 may be a wireless connection. Theconnection 3670 may take the form of any sort of wireless connection,including but not limited to Bluetooth connectivity, Wi-Fi connectivity,cellular data network connectivity (e.g., 3G, 4G, LTE, 5G), anotherwireless protocol, or any combination thereof. Other possible modes ofwireless communication may include near-field communications, such aspassive radio-frequency identification (RFID) and active (RFID)technologies. RFID and similar near-field communications may allow thevarious devices to communicate in short range when they are placedproximate to one another. In an embodiment using near fieldcommunication, two devices may have to physically (or very nearly) comeinto contact, and one or both of the devices may sense various data suchas acceleration, position, orientation, velocity, change in velocity, IPaddress, and other sensor data. The system can then use the varioussensor data to confirm a transmission of data over the internet betweenthe two devices. In yet another embodiment, the devices may connectthrough an internet (or other network) connection. That is, theconnection 3670 may represent several different computing devices andnetwork components that allow the various devices to communicate throughthe internet, either through a hard-wired or wireless connection. Theconnection 3670 may also be a combination of several modes ofconnection.

To operate different embodiments of the system or programs disclosedherein, the various devices may communicate in different ways. Forexample, the autoinjector device 3600 may download various softwareapplications from the server 3625 through the internet. Such softwareapplications may allow the various devices disclosed herein to performsome or all of the processes and functions described herein. In anotherembodiment, the autoinjector device 3600 may operate using internetbrowsers that can access websites that perform the functionality of anyof the systems and methods disclosed herein. Additionally, theembodiments disclosed herein are not limited to being performed only onthe disclosed devices in FIG. 36. It will be appreciated that manyvarious combinations of computing devices may also communicate with anautoinjector and assist in executing the methods and systems disclosedherein. Examples of such computing devices may include smart phones,personal computers, servers, laptop computers, tablets, blackberries,RFID enabled devices, or any combinations of such devices.

The configuration of the devices in FIG. 36 is merely one physicalsystem on which the disclosed embodiments may be executed. Otherconfigurations of the devices shown may exist to practice the disclosedembodiments. Further, configurations of additional or fewer devices thanthe ones shown in FIG. 36 may exist to practice the disclosedembodiments. Additionally, the devices shown in FIG. 36 may be combinedto allow for fewer devices or separated where more than the two devicesshown exist in a system.

In some embodiments, systems and methods for automatically removing aneedle cap may be implemented on any device/injector having a needle.

In some embodiments, systems and methods for automatically removing aneedle cap may be implemented on an injector assembly for automaticallydelivering a dose of a medicament to a subject in a controlled manner.Such an injector assembly may include, for example, an activation switchfor initiating automatic delivery of the dose of the medicament, aneedle aperture at a distal end of the injector assembly and forenabling an injection needle to pass there through, a plunger drivemechanism for applying pressure to the plunger assembly, and a cavityfor housing at least a portion of a removable cartridge module. Theremovable cartridge module may include (a) a needle housing fordictating the range of injection depths or possible, (b) a plungerhousing for aligning a plunger assembly with the plunger drive unit, (c)an identification code associated with the medicament, and (d) a cavityfor reversibly securing a pre-filled cartridge in the properorientation.

In these embodiments, the removable cartridge module may be similar tothe dose cassette described above, for example, with respect to FIGS.11-14. Further, the injector assembly may include mechanisms forremoving the needle cap similar to mechanisms describe above withrespect to, for example, FIGS. 9-22. Thus, the removable cartridgemodule may include a needle cap 108 that may be automatically removed bythe injector assembly.

In one embodiment, the pre-filled cartridge includes: (i) a barrel forcontaining the medicament and having a proximal end and a distal end,(ii) a needle operably connected to the distal end of the barrel, (iii)a plunger assembly including a plunger rod having a distal end initiallylocated near the proximal end of the barrel, and a proximal endincluding a plunger head, and (iv) an amount of the medicament.

In one embodiment, the plunger drive mechanism includes a motor operablyconnected to the activation switch (e.g. a button, toggle, lever, dial,rocker or similar) and an actuator operably connected to the motor andthe plunger assembly; at least one engagement feature for securing theremovable cartridge module in the cavity in the proper orientation; adoor, at least a portion of which is optionally substantiallytransparent, for enabling installation and/or removal of the removablecartridge module to/from the injector cavity, as well as loading and/orremoval of the pre-filled cartridge to/from the installed cartridgemodule cavity; a cartridge module drive assembly for moving thecartridge module axially towards the proximal and distal end of theinjector assembly, the cartridge module drive assembly including atleast one gear element operably connected to the motor and theactivation switch; a code reader for reading an identification codeassociated with the pre-filled cartridge and the medicament containedwithin the cartridge; a sensor for detecting contact with skin of thesubject; a battery operably connected to the motor; a control unit (e.g.microcontroller) with associated memory containing a library ofinjection programs and operably connected to the sensors, code reader,drive mechanism(s) and activation switch.

In some embodiments, a cartridge module may include a needle housing fordictating the range of injection depths possible; a plunger housing foraligning a plunger assembly with the plunger drive unit; a cavity forreversibly securing a cartridge pre-filled with a medicament; anidentification code associated with the pre-filled cartridge and themedicament contained within; at least one fitting for removably engagingthe cartridge module with the injector assembly in the properorientation; and at least one fitting for engaging the cartridge modulewith a cartridge module drive assembly, optionally wherein the cartridgedrive assembly is integrated with the injector assembly.

The above detailed descriptions of embodiments of the technology are notintended to be exhaustive or to limit the technology to the precise formdisclosed above. Although specific embodiments of, and examples for, thetechnology are described above for illustrative purposes, variousequivalent modifications are possible within the scope of thetechnology, as those skilled in the relevant art will recognize. Forexample, while steps are presented in a given order, alternativeembodiments may perform steps in a different order. The variousembodiments described herein may also be combined to provide furtherembodiments.

From the foregoing, it will be appreciated that specific embodiments ofthe technology have been described herein for purposes of illustration,but well-known structures and functions have not been shown or describedin detail to avoid unnecessarily obscuring the description of theembodiments of the technology. Where the context permits, singular orplural terms may also include the plural or singular term, respectively.

Moreover, unless the word “or” is expressly limited to mean only asingle item exclusive from the other items in reference to a list of twoor more items, then the use of “or” in such a list is to be interpretedas including (a) any single item in the list, (b) all of the items inthe list, or (c) any combination of the items in the list. Additionally,the term “comprising” is used throughout to mean including at least therecited feature(s) such that any greater number of the same featureand/or additional types of other features are not precluded. It willalso be appreciated that specific embodiments have been described hereinfor purposes of illustration, but that various modifications may be madewithout deviating from the technology. Further, while advantagesassociated with certain embodiments of the technology have beendescribed in the context of those embodiments, other embodiments mayalso exhibit such advantages, and not all embodiments need necessarilyexhibit such advantages to fall within the scope of the technology.Accordingly, the disclosure and associated technology can encompassother embodiments not expressly shown or described herein.

1. An autoinjector device comprising: a dose cassette comprising: anouter container and a needle cap having a base with a diameter largerthan the outer container of the dose cassette; a housing for receivingthe dose cassette; a clasp mechanism configured to hold the dosecassette within the housing; and an actuator configured to move the dosecassette proximally within the housing after the dose cassette issecured within the housing, wherein: the movement of the dose cassettecauses the base of the needle cap to mechanically engage with a distalend of the housing, and the mechanical engagement between the base ofthe needle cap and the distal end of the housing causes the needle capto separate from the dose cassette.
 2. The autoinjector device of claim1, further comprising a sensor at the distal end of the housingconfigured to detect a presence of the base of the needle cap.
 3. Theautoinjector device of claim 2, wherein the sensor is further configuredto detect that the needle cap has separated from the dose cassette. 4.The autoinjector device of claim 3, wherein the dose cassette comprisesa medicament, and wherein the autoinjector device is configured todeliver the medicament after detecting that the needle cap has separatedfrom the dose cassette.
 5. The autoinjector device of claim 1, whereinthe needle cap further comprises a needle shield portion sized to fitwithin a needle opening of the outer container of the dose cassette. 6.The autoinjector device of claim 1, wherein the dose cassette furthercomprises an inner container configured to store a medicament.
 7. Theautoinjector device of claim 1, wherein the outer container of the dosecassette comprises a ledge and the clasp mechanism comprises a baselatch configured to fix to the ledge and thereby secure the dosecassette within the housing.
 8. The autoinjector device of claim 7,wherein a distal end of the base latch comprises a ramp surface and alocking surface, wherein during an insertion of the dose cassette, theouter container of the dose cassette is configured to mechanicallyengage with the ramp surface and push the distal end of the base latchradially outward until the distal end of the base latch reaches theledge.
 9. The autoinjector device of claim 8, wherein upon reaching theledge, the distal end of the base latch moves radially inward into aspace in the outer container of the dose cassette at the ledge.
 10. Theautoinjector device of claim 9, wherein the locking surface contacts theouter container at the ledge after the base latch moves radially inwardinto the space in the outer container.
 11. The autoinjector device ofclaim 7, wherein the base latch is operably connected to the actuator,and the actuator is configured to move the dose cassette proximallywithin the housing by moving the base latch.
 12. A method comprising:receiving a dose cassette into a housing, wherein the dose cassettecomprises an outer container and a needle cap having a base with adiameter larger than the outer container; holding the dose cassettewithin the housing using a clasp mechanism; moving the dose cassetteproximally within the housing after the dose cassette is secured withinthe housing; and separating the needle cap from the dose cassettebecause of mechanical engagement between a distal end of the housing andthe needle cap.
 13. The method of claim 12, further comprising: sensinga presence of the base of the needle cap at the distal end of thehousing, wherein the dose cassette is moved proximally within thehousing to separate the needle cap from the dose cassette only after thepresence of the base of the needle cap is sensed at the distal end ofthe housing.
 14. (canceled)
 15. The method of claim 12, furthercomprising: determining that the needle cap has separated from the dosecassette; and delivering a medicament of the dose cassette only afterdetermining that the needle cap has separated from the dose cassette.16. (canceled)
 17. The method of claim 12, wherein the outer containerof the dose cassette comprises a ledge and the clasp mechanism comprisesa base latch, and wherein the method further comprises securing the dosecassette within the housing by fixing the base latch to the ledge. 18.The method of claim 17, wherein: a distal end of the base latchcomprises a ramp surface and a locking surface, and during an insertionof the dose cassette into the housing, the outer container of the dosecassette mechanically engages with the ramp surface and pushes thedistal end of the base latch radially outward until the distal end ofthe base latch reaches the ledge.
 19. The method of claim 18, whereinupon reaching the ledge, the distal end of the base latch moves radiallyinward into a space in the outer container of the dose cassette at theledge.
 20. The method of claim 19, wherein the locking surface contactsthe outer container at the ledge after the base latch moves radiallyinward into the space in the outer container.
 21. The method of claim17, wherein the moving of the dose cassette proximally within thehousing occurs by moving the base latch proximally within the housing,wherein the base latch is operably connected to the actuator.
 22. A dosecassette, comprising: an outer container; an inner container configuredto store medicament; and a needle cap comprising a base with a diameterlarger than the outer container of the dose cassette and a needle shieldportion configured to fit within a needle opening of the outer containerof the dose cassette, wherein: the outer container is configured to beinserted into a housing of an autoinjector and comprises a ledgeconfigured to attach to a clasp mechanism of the autoinjector, the baseof the needle cap is configured to mechanically engage with a distal endof the housing, and the needle cap is configured to separate from theouter container as a result of the mechanical engagement between thedistal end of the housing and the base of the needle cap. 23-30.(canceled)